LGC SeraCare is pleased to announce that the AccuPlex™ SARS-CoV-2 Reference Material Kit v2 is now CE marked for in vitro diagnostic use (CE-IVD). With this change in regulatory status, the new product name is AccuPlex SARS-CoV-2 Molecular Controls Kit. Bearing the CE mark and IVD symbol signifies that the AccuPlex SARS-CoV-2 Molecular Controls Kit meets extensive design control requirements.
LGC SeraCare continues to innovate its portfolio of products supporting SARS-CoV-2 diagnostics. Initially designed to target the published CDC and WHO consensus sequences, the new AccuPlex™ SARS-CoV-2 Verification Panel and Reference Material Kit are now available with full SARS-CoV-2 viral genome coverage. This expansion allows for compatibility with any SARS-CoV-2 assay target, while maintaining the safety features and performance monitoring advantages of AccuPlex technology.
LGC SeraCare Expands its SARS-CoV-2 Serology Offering with 11-Member, Positive-Patient Performance Panel
LGC SeraCare has released the AccuSet™ SARS-CoV-2 Performance Panel, intended for use by clinical laboratories and diagnostic manufacturers alike, to evaluate SARS-CoV-2 antibody assays.
LGC SeraCare has released ACCURUN® Anti-SARS-CoV-2 Reference Materials to address the critical need for clinical laboratories to be able to report antibody testing results with confidence, in response to the ongoing COVID-19 pandemic. The ACCURUN kit is designed to support assay installation as well as to monitor day-to-day assay performance, as required by CLIA, CAP, ISO-15189 and many other regulatory or accrediting bodies, providing a complete quality solution for SARS-CoV-2 antibody testing.
In response to the critical need for accurate testing to combat the COVID-19 pandemic, LGC SeraCare continues to innovate and expand their novel AccuPlex™ SARS-CoV-2 Quality Solutions in support of improved diagnostic assay development and testing.
LGC’s Clinical Diagnostics Business Unit expands production of AccuPlex™ COVID-19 reference materials to support global diagnostic assay development efforts
With the rapid global spread of the SARS-CoV-2 virus and the urgent need for reliable diagnostic solutions, LGC’s SeraCare Life Sciences is expanding production of their novel COVID-19 reference materials to include high titer stocks that serve as a valuable tool for diagnostic manufacturers.
IQN Path Selects SeraCare Life Sciences for First-Ever Tumor Mutational Burden External Quality Assessment Program
SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, announced today their successful selection as a technology partner in support of the first ever tumor mutational burden (TMB) external quality assessment (EQA) program being developed by the International Quality Network for Pathology (IQN Path).
Today, LGC announced the acquisition of SeraCare Life Sciences, Inc., a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories.
SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, announced today an exclusive partnership with AccuRef Diagnostics, a Division of Applied StemCell, Inc., to market and sell their broad portfolio of CRISPR-engineered cell line reference materials.
SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, announced today the commercial launch of an expanded neurotrophic tropomyosin receptor kinase (NTRK) RNA fusion reference material panel developed in a partnership with Bayer.
Pioneering Survey of Clinical NGS QC Practices Proves Need for Purpose-Built QC Solutions to Standardize Industry
SeraCare Life Sciences has partnered with GenomeWeb to conduct a first-of-its-kind survey for clinical NGS labs with over 150 respondents providing comprehensive data detailing their QC management programs.
SeraCare Announces the Expansion of Their Proprietary AccuPlex™ Technology Product Portfolio with the Launch of the AccuSpan™ HCV RNA Linearity Panel
Announcing the launch of their all-new AccuSpan™ HCV RNA Linearity Panel – the latest product built with their proprietary AccuPlex™ recombinant technology
SeraCare Partners with NAVICAN on Implementation of Best-In-Class QC Workflow for TheraMap Precision Cancer Care™ Services
Leading NGS QC Software is integrated into their Philips IntelliSpace Genomics Platform
Comprehensive circulating tumor DNA reference materials for NGS assay development, validation, and daily run controls
SeraCare Announces Industry’s First CNV-Specific Reference Material for Gene Amplifications in Breast, Lung, and Brain Cancer
Truth-set NGS reference materials that broaden capabilities for tumor profiling assay validation and QC
SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, today announced that Joe Bernardo has joined SeraCare’s board of directors in the role of Chairman
SeraCare Announces Industry's First Comprehensive NGS Reference Material for Hematologic Malignancies
Truth-set NGS reference materials to significantly advance validation and QC of myeloid assays
SeraCare Announces the Launch of a Suite of Zika Virus Reference Materials for Improved Diagnostic Testing
Comprehensive suite of Zika IgM and recombinant Zika virus reference materials for method validation and evaluation of serological and molecular infectious disease assays.
Truth set ctDNA materials to significantly advance the development and validation of liquid biopsy assays